VOCSN Patient Breathing Package Adult, Active, Heated, Oxygen, BlueRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00850018761062), received between Jul 25, 2024 and Aug 7, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 reports).

5 other recalls cover devices cleared under the same FDA submission (K162877); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934640 ↗
• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934578 ↗
• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934478 ↗
• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934212 ↗
• MalfunctionAug 7, 2024Material Separation; Output Problem; Material Separation; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. STAFF AT THE FACILITY ADVISED VENTEC THAT THEY INITIALLY OBSERVED THAT THE VENTILATOR'S EXHALED TIDAL VOLUME (VTE) LEVELS HAD DROPPED BY 40-60%, AS WELL AS CHANGES IN OTHER VENTILATOR PARAMETERS (HIGH LEAK, LOW TIDAL VOLUMES, ETC.). THEY FURTHER ADVISED THAT O2 DELIVERY WAS ALSO IMPACTED FOR PATIENTS WHO WERE USING THE INTERNAL CONCENTRATOR. STAFF THEN OBSERVED THAT THE PATIENT CIRCUIT WAS BROKEN AND CHANGED IT OUT TO RESOLVE THE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934134 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931528 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931342 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931314 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931109 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930893 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930626 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

  IT WAS REPORTED TO VENTEC THAT THE O2 DELIVERY TUBE PORTION OF THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE) HAD SEPARATED FROM THE MAIN TUBING ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930603 ↗
• MalfunctionJul 25, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DISPLAYING A "PATIENT CIRCUIT DISCONNECT" ALARM. THE REPORTER ADVISED THAT THEY BELIEVED THERE WAS AN ISSUE WITH THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE). AFTER TRYING MULTIPLE CIRCUITS UNSUCCESSFULLY, THE PATIENT WAS THEN PLACED ON ANOTHER MANUFACTURER'S DEVICE FOR SUPPORT. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS REACHED OUT TO THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833742 ↗
• MalfunctionJul 25, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DISPLAYING A "PATIENT CIRCUIT DISCONNECT" ALARM. THE REPORTER ADVISED THAT THEY BELIEVED THERE WAS AN ISSUE WITH THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE). AFTER TRYING MULTIPLE CIRCUITS UNSUCCESSFULLY, THE PATIENT WAS THEN PLACED ON ANOTHER MANUFACTURER'S DEVICE FOR SUPPORT. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS REACHED OUT TO THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833668 ↗
• MalfunctionJul 25, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DISPLAYING A "PATIENT CIRCUIT DISCONNECT" ALARM. THE REPORTER ADVISED THAT THEY BELIEVED THERE WAS AN ISSUE WITH THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE). AFTER TRYING MULTIPLE CIRCUITS UNSUCCESSFULLY, THE PATIENT WAS THEN PLACED ON ANOTHER MANUFACTURER'S DEVICE FOR SUPPORT. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS REACHED OUT TO THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833659 ↗
• MalfunctionJul 25, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DISPLAYING A "PATIENT CIRCUIT DISCONNECT" ALARM. THE REPORTER ADVISED THAT THEY BELIEVED THERE WAS AN ISSUE WITH THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE). AFTER TRYING MULTIPLE CIRCUITS UNSUCCESSFULLY, THE PATIENT WAS THEN PLACED ON ANOTHER MANUFACTURER'S DEVICE FOR SUPPORT. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS REACHED OUT TO THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833649 ↗
• MalfunctionJul 25, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DISPLAYING A "PATIENT CIRCUIT DISCONNECT" ALARM. THE REPORTER ADVISED THAT THEY BELIEVED THERE WAS AN ISSUE WITH THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE). AFTER TRYING MULTIPLE CIRCUITS UNSUCCESSFULLY, THE PATIENT WAS THEN PLACED ON ANOTHER MANUFACTURER'S DEVICE FOR SUPPORT. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS REACHED OUT TO THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833626 ↗
• MalfunctionJul 25, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DISPLAYING A "PATIENT CIRCUIT DISCONNECT" ALARM. THE REPORTER ADVISED THAT THEY BELIEVED THERE WAS AN ISSUE WITH THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE). AFTER TRYING MULTIPLE CIRCUITS UNSUCCESSFULLY, THE PATIENT WAS THEN PLACED ON ANOTHER MANUFACTURER'S DEVICE FOR SUPPORT. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS REACHED OUT TO THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833618 ↗
• MalfunctionJul 25, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DISPLAYING A "PATIENT CIRCUIT DISCONNECT" ALARM. THE REPORTER ADVISED THAT THEY BELIEVED THERE WAS AN ISSUE WITH THE PATIENT CIRCUIT (ADULT, ACTIVE, HEATED, OXYGEN, BLUE). AFTER TRYING MULTIPLE CIRCUITS UNSUCCESSFULLY, THE PATIENT WAS THEN PLACED ON ANOTHER MANUFACTURER'S DEVICE FOR SUPPORT. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS REACHED OUT TO THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833594 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162877. One submission often covers many models, so check the product and lot details in each record.

• Z-2525-2026 · May 8, 2026 · Open, Classified
  VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
• Z-1942-2026 · Mar 25, 2026 · Open, Classified
  VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
• Z-1196-2025 · Feb 3, 2025 · Open, Classified
  VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
• Z-1070-2024 · Jan 9, 2024 · Open, Classified
  VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides c
• Z-1902-2021 · May 10, 2021 · Open, Classified
  Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900